XTL is a clinical-stage biotech dedicated to developing pharmaceutical products to treat autoimmune diseases such as lupus. The biotech’s lead drug candidate, hCDR1, is a top-quality clinical asset for the treatment of systemic lupus erythematosus (SLE). The drug hCDR1 has comprehensive clinical data in three trials of over 400 patients which showed the novel compound has a favorable safety profile, is well-tolerated by patients and is efficient in several clinically meaningful endpoints. The company expects to initiate a Phase 2 clinical trial of hCDR1 in 2016.
“We are very pleased to accept the Lupus Foundation of America’s invitation to join its Corporate Advisory Council and work with our co-members in an effort to advance effective treatments for systemic lupus erythematosus (SLE), which continues to represent a significant unmet medical need,” XTL’s CEO, Josh Levine, said in a press release. “We look forward to an exchange of industry-advancing ideas with colleagues and sharing our development experience with our lead asset, hCDR1.”
“Having recently received encouraging feedback from the U.S. Food and Drug Administration on our pre-investigational new drug [IND] meeting package for hCDR1 in the treatment of SLE, we expect to file the IND shortly and initiate the Phase 2 study in the second half of 2016,” Levine said.
The LFA-CAC is a partnership of biotech and biopharma industry representatives established by the LFA to accelerate the development of an arsenal of treatments for lupus and getting them to the people who need it the most.
“We welcome XTL Biopharmaceuticals as a new member of our Corporate Advisory Council,” LFA President and CEO Sandra C. Raymond said. “XTL joins our global network of lupus scientists, physicians, industry leaders and people with lupus to help improve how new drugs are tested and evaluated so we can deliver more targeted and safer treatments to people with lupus faster. We are pleased to see the re-emergence of research on the drug candidate, hCDR1 (edratide), as a potential new treatment for lupus under XTL.”